ANDAs impurities in drug substances - Pharmanet
ANDAs impurities in drug substances - Pharmanet
ANDAs impurities in drug substances - Pharmanet
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Draft-Not for ImplementationAttachment IImpurities Decision Tree(Generic Drugs)L1Decrease impurity levelbelow thresholdYesAbove ThresholdNoQualifiedL2Decrease belowthresholdNoYesStructure elucidated?YesNoIs the impurityobserved <strong>in</strong> the<strong>in</strong>novator’s <strong>drug</strong>product and at asimilar level?No* Toxicity documented andsufficient?YesL3aNo• Compliance with a USP <strong>drug</strong>substance specification foran identified impurity?YesNoL3bDecrease belowthresholdNo• Is the impurity observed <strong>in</strong>the <strong>in</strong>novator’s <strong>drug</strong> productand at a similar level?YesQualifiedNoL3cNo• If at a higher level, or a newimpurity is detected…is it qualified from thescientific literature?YesNoYesL4NoRelated to others withknown toxicity?YesAcceptableJustification**NoL5Decrease belowthresholdNoQualified by a simplebattery ofgenotoxicity tests?YesQualifiedNoL6NoQualified by additionaltoxicity test<strong>in</strong>g?YesQualifiedbut not 505(j)* Generic Drug Pathway** e.g., qualified by QSARJ:\!GUIDANC\2452DFT.WPDJuly 21, 199812